Oxcarbazepine
NDC Package 42291-661-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). Marketed by Avkare, Inc., this product is identified by NDC 42291-661 and is authorized under FDA application ANDA202961.

Identification & Billing

NDC Package Code
42291-661-25
Package Description
1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE
Product Code
42291-661
11-Digit Billing Format
42291066125
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Oxcarbazepine
Dosage Form
-
Usage Information
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

Regulatory & Marketing

Labeler Name
Avkare, Inc.
FDA Application #
ANDA202961
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-23-2014
End Marketing Date
04-18-2016
Listing Expiration
04-18-2016
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-661-25 identifies a specific commercial package of 1 bottle in 1 carton / 250 ml in 1 bottle of Oxcarbazepine, labeled by Avkare, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avkare, Inc. on January 23, 2014. The current certification is valid through April 18, 2016.

What are the primary indications for this medication?

Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

How is this Avkare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291066125. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42291-661-25
11-Digit CMS (5-4-2)
42291-0661-25

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.